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The NPD 1000 Negative Pressure Wound Therapy System is a portable, low-powered, battery-operated suction pump intended for the application of suction to remove a small amount of fluid from the wound bed including wound exudate and infectious material which may promote wound healing.

The NPD 1000 Negative Pressure Wound Therapy System includes a small, portable, low powered, battery operated electromechanical pump used with an accessory wound dressing. The system uses controlled negative pressure (vacuum) to remove exudates, which may promote wound healing.

The provided text is a 510(k) Summary for the NPD 1000 Negative Pressure Wound Therapy System. This document outlines the device description, intended use, and claims substantial equivalence to predicate devices based on similarities in principles of operation, technology, and indications for use.

Crucially, the provided text does not contain any acceptance criteria or the results of a study proving the device meets acceptance criteria.

The "Functional and Safety Testing" section only mentions that representative samples underwent "functional and mechanical testing, EMC testing in accordance with IEC 60601-1-2:2001 and electrical safety testing in accordance with UL 60601-1:2006." This indicates that some testing was performed but does not specify the acceptance criteria for these tests, nor does it provide any reported performance data against such criteria. Studies demonstrating clinical effectiveness or specific performance metrics related to wound healing or fluid removal are not detailed.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a medical device, not an AI/imaging device, so this type of study is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a medical device, not an AI/imaging device, so this type of study is not applicable and not mentioned.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating equivalence to predicate devices through design and intended use, rather than presenting detailed performance data from clinical or rigorous non-clinical studies with defined acceptance criteria.

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